PARTICIPANT'S BILL OF RIGHTS

The Pennington Center is committed to protecting the rights, safety and well being of all individuals who volunteer to participate in research conducted at the Center. The Institutional Review Board (IRB) is an independent body consisting of medical, scientific, and nonscientific members from both the Pennington Center and the Baton Rouge community. It is the responsibility of the IRB to rigorously review all research involving human volunteers to ensure that

Risks to volunteers are minimized through sound scientific research design

Risks to volunteers are reasonable in relation to anticipated benefits

The selection of volunteers is equitable, and any vulnerable populations such as children are adequately protected

Informed consent is obtained from each volunteer after study procedures are thoroughly explained

Adequate procedures are in place to protect the privacy of volunteers

A study may not begin to accrue volunteers until it has been approved by the IRB. Once a study has begun, the IRB monitors each study through continuing reviews conducted on a periodic basis to ensure that the interests of study participants remain protected. The IRB assures compliance with the Department of Health and Human Services (DHHS) regulations (45 CFR 46) and with the Food and Drug Administration (FDA) regulations (21CFR 50and 21 CFR 56).

As a volunteer in a research study, you have the following rights:

To be told what the study is trying to find out

To be told what will happen to me if you take part in the study

To be told about the frequent and/or important risks, side effects, or discomforts of the things that will happen to you for research purposes

To be told if you can expect any benefit from participating, and if so, what the benefit might be

To be assured that study records will remain confidential to the extent allowed by law

To be told what compensation you will receive and what charges you will pay

To be told about any new findings that may affect my willingness to continue participating in the study

To be told of the other choices you have if you decide not to take part in the study

To be allowed to ask any questions concerning the study both before agreeing to participate and during the course of the study

To be told what sort of medical treatment is available if any complications arise

To refuse to participate at all or to change your mind about participating after the study is started without penalty

To receive a copy of the signed and dated consent form

To be free of pressure when considering whether you wish to agree to participate in the study

If you have other questions please ask the principal investigator. You may also contact the Pennington Center Institutional Review Board (IRB), which is concerned with the protection of volunteers in research studies.

You may reach the IRB office by calling:
(225) 763-2693 from 8:00 AM to 5 PM Monday through Friday,
or by writing to the Pennington Biomedical Research Center IRB,
6400 Perkins Road, Baton Rouge, LA 70808.